Health Technology Preparation & Submission

Odelle Technology

United Kingdom

Service ID:

EP299S3
Service description

Preparing and submitting health technology applications is a complex process—one that requires deep regulatory knowledge, scientific clarity, and strategic positioning. At Odelle Technology, we specialise in guiding health innovators through each step of the HTA journey, from early planning to final submission and post-market support.  With over 15 years of experience, our expert team provides tailored support across a range of services, including systematic reviews, economic modelling, value dossiers, stakeholder engagement, and regulatory alignment. We don’t believe in a one-size-fits-all approach;instead, we build bespoke strategies that reflect the unique clinical and economic value of your technology.  We ensure compliance with national and EU regulatory requirements, supporting submissions across France (HAS), Germany (G-BA/IQWiG), the UK (NICE), and beyond. Our insights help navigate evolving HTA guidelines while anticipating market needs and payer expectations.  Odelle also supports post-market surveillance, including adverse event monitoring and reporting frameworks—helping maintain compliance, safety, and long-term clinical value.  We have successfully engaged directly with European HTA bodies to demonstrate the value of emerging technologies, reduce uncertainty, and accelerate adoption. Our goal is to maximise your chance of success—and ensure your innovation reaches the patients who need it.

Sector
Digital and Information communication technology
Health and medical care
Pharmaceuticals
Technology Readiness Level
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Financial requirements

€2000.

Disclaimer related to service

Project timelines and deliverables will be outlined in the agreed Statement of Work or client contract. Any deadlines indicated are target dates and may be adjusted in consultation with the client based on the availability of key information, stakeholder input, and third-party dependencies (e.g. ethics approvals, regulatory responses, pilot site readiness).  Odelle does not offer legal representation, clinical trial sponsorship, or regulatory approval services. Clients are responsible for ensuring that the outputs provided are reviewed in line with their internal governance processes and applicable national regulations.

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